Sr Supplier Quality Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Cincinnati, Ohio, United States of America, Ciudad Juarez, Chihuahua, Mexico, Guaynabo, Puerto Rico, United States of America

Job Description:

Ethicon Endo-Surgery is recruiting for a Senior Supplier Quality Engineer. The preferred location is Cincinnati, OH. However, the position can also be in Juarez, Mexico or Guaynabo, Puerto Rico.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

The position of Supplier Quality Engineer is responsible for support and leadership of Quality Engineering activities in New Product Development and ongoing manufacturing – including resolution of non-conformances (root cause & corrective action), CAPA, Quality System and process improvement activities

Key Responsibilities:

• Provide leadership in design & implementation of world-class quality Engineering to support entire product life cycle with focus on quality engineering activities such as reliability, root cause/corrective action risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the products.
• Activities include driving correction, corrective action, prevention, detection of defects at the earliest phase of product design, continuous improvement & customer satisfaction.
• Provide leadership and technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems.
• Provide review and approvals for the release of new products ensuring quality requirements are met.
• Provide leadership & support to J&J process excellence initiatives including Six-Sigma, design excellence & lean thinking.
• Direct development & consistent application of quality policies & procedures in product design & development, secondary development, manufacturing, external manufacturers & suppliers.
• Responsible for following and administering safety.
• Compliance with safety policies and procedures.
• Follow J&J and EES Records Management Policies for Convenience Information, Records Retention Schedules, Training and Education, Document Hold Notices, Records Cleanout, Inactive Records and Information Management, Vital Records and third-party vendor if applicable.
• Other responsibilities may be assigned and not all responsibilities listed may be assigned
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Qualifications

Education:

• A Bachelor or equivalent degree in Engineering or applicable sciences is required. Other Bachelor/Master degrees acceptable with applicable work experience in a regulated industry. Electrical Engineering Degree preferred.

Experience and Skills

Required:

• 2-4 years of related work experience
• Regulatory compliance knowledge: GMP, MDD (Medical Devices Directive), 510K (Pre-market approval), and Government, trade association, industry & medical publications
• Strong communication skills (written and verbal)
• Negotiation and influencing skills
• Effective assertiveness and quality assurance
• Analytical and creative thinking abilities
• Project management skills to handle multiple initiatives concurrently
• Problem-solving and prioritization capabilities
• Strong organizational skills and ability to synthesize information from diverse sources
• Rapid comprehension of complex concepts
• Continuous research and ongoing learning of industry trends and regulatory requirements
• Proficiency in personal computer applications

Preferred:

• Experience working with medical device external manufacturers for Capital Equipment and/or PCBA assembly and production

Other:

• English proficiency (written and verbal) is required
• This position may require up to 25% travel
• Preferred certifications: CQA, CQE, CRE, Six Sigma GB or BB

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

The anticipated base pay range for this position is :

$77,000- $124,200

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. • Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). • Employees are eligible for the following time off benefits: • Vacation – up to 120 hours per calendar year • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year • Holiday pay, including Floating Holidays – up to 13 days per calendar year • Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. For additional general information on Company benefits, please go to: • https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.